Design and Development Procedure

Description

The purpose of presenting the design-and-development procedure is to enable the implementation and deployment of a quality management system (ISO 9001:2015) by young consultants and industrial engineers.

Design and Development Procedure has contained the text of the procedure based on ISO 9001:2015 (Claus 8.3) which details all steps of design and development from receiving inputs to verification and validation of outputs and then making required models.

ISO 9001:2015 (Claus 8,3):

8.3 Design and development of products and services
8.3.1 General
The organization shall establish, implement and maintain a design and development process that is
appropriate to ensure the subsequent provision of products and services.
8.3.2 Design and development planning
In determining the stages and controls for design and development, the organization shall consider:
a) the nature, duration, and complexity of the design and development activities;
b) the required process stages, including applicable design and development reviews;
c) the required design and development verification and validation activities;
d) the responsibilities and authorities involved in the design and development process;
e) the internal and external resource needs for the design and development of products and services;
f) the need to control interfaces between persons involved in the design and development process;
g) the need for involvement of customers and users in the design and development process;
h) the requirements for subsequent provision of products and services;
i) the level of control expected for the design and development process by customers and other
relevant interested parties;
j) the documented information needed to demonstrate that design and development requirements
have been met.
8.3.3 Design and development inputs
The organization shall determine the requirements essential for the specific types of products and
services to be designed and developed. The organization shall consider:
a) functional and performance requirements;

8. b) information derived from previous similar design and development activities;
   c) statutory and regulatory requirements;
   d) standards or codes of practice that the organization has committed to implement;
   e) potential consequences of failure due to the nature of the products and services.
   Inputs shall be adequate for design and development purposes, complete and unambiguous.
   Conflicting design and development inputs shall be resolved.
   The organization shall retain documented information on design and development inputs.
   3.4 Design and development controls
   The organization shall apply controls to the design and development process to ensure that:
   a) the results to be achieved are defined;
   b) reviews are conducted to evaluate the ability of the results of design and development to meet
   requirements;
   c) verification activities are conducted to ensure that the design and development outputs meet the
   input requirements;
   d) validation activities are conducted to ensure that the resulting products and services meet the
   requirements for the specified application or intended use;
   e) any necessary actions are taken on problems determined during the reviews, or verification and
   validation activities;
   f) documented information of these activities is retained.
   NOTE Design and development reviews, verification and validation have distinct purposes. They can be
   conducted separately or in any combination, as is suitable for the products and services of the organization.
   8.3.5 Design and development outputs
   The organization shall ensure that design and development outputs:
   a) meet the input requirements;
   b) are adequate for the subsequent processes for the provision of products and services;
   c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;
   d) specify the characteristics of the products and services that are essential for their intended purpose
   and their safe and proper provision.
   The organization shall retain documented information on design and development outputs.
   8.3.6 Design and development changes
   The organization shall identify, review and control changes made during, or subsequent to, the design
   and development of products and services, to the extent necessary to ensure that there is no adverse
   impact on conformity to requirements.
   The organization shall retain documented information on:
   a) design and development changes;
   b) the results of reviews;
9. c) the authorization of the changes;
   d) the actions taken to prevent adverse impacts.